Pharmaceutical Companies Using Children in Poorer Countries to Test Medications for Developed World

Drug companies are using children in developing world countries like Uganda and India to test experimental medications.

In 1997, US legislators passed a law called the Pediatric
Exclusivity Provision. This law offered a financial incentive to drug companies
to develop medications for children by giving an extra 6 months of patent
protection on medications that would normally only be tested and available for
adults, if these companies would also run trials to approve these medications
for children.

Since the passing of this law, more than 150 drugs for
children have received FDA approval, but Duke University
medical researchers found that a third of published clinical trials performed
under this provision involved children from poorer developing world countries.

Lead researcher Dr. Sara K. Pasquali of Duke University
said that using children from poorer countries to test medications destined for
children in developed world nations certainly raised some ethical issues, saying,
"Oftentimes, access to a study may be the only access to medical care a
family has. Once the testing is done, however, it's unclear if effective drugs
will be marketed in the country in question, and whether they will be
affordable.”

Mark Grayson, a spokesperson for the Pharmaceutical Research
and Manufacturers of America says, however, that there’s nothing wrong with
performing clinical trials outside of the US
because the trials are conducted in the same way they would be in the US, saying, "All
of our companies follow our principles on conducting clinical trials. No matter
where we are we follow our principles.”

Although drug makers may follow established trials protocols
when conducting testing outside of the US, some critics, like McMaster University
Pharmacologist M. Nabeel Ghayur, say that the way things are done in some
developing world countries make protocols like informed consent far less meaningful.

Ghayur, who has worked in drug development in Pakistan
commented, saying, "Recruiting people is easy, getting informed consent is
easy, getting approval is easy, paying the patients and paying the doctors is
easy. The physicians and investigators have absolutely no idea about the
seriousness of the situation….People actually have blind trust in their doctor
in South Asia. They have no idea what drug
development is, they have no idea what clinical trials are”